The purpose of this study is to evaluate the clinical performance of the AnyplexTM II HPV HR Detection (Seegene, Korea), a new multiplex real-time PCR assay, relative to Hybrid Capture 2 (HC2, Qiagen, USA) for a primary screening tool in cervical screening.

Methods:

A total of 1,143 specimens in a Huro Path solution (CelltraZone, Korea) were included into the study . Upon cytological examination, most cases were diagnosed as normal: 870 normal, 85 atypical squamous cells of undetermined significance [ASCUS], 44 low-grade squamous intraepithelial lesion [LSIL], 80 atypical squamous cells, cannot rule out a high a high grade lesion [ASC-H], and 64 high-grade squamous intraepithelial lesion [HSIL]. All residual specimens was divided into two aliquots and then submitted for two methods according to manufacturer’s instruction. Clinical sensitivity and specificity, intra- and inter -laboratory reproducibility were evaluated using the Meijer et al. international guidelines.

Results:

There was a overall concordance rate of 91.3% between the results of the AnyplexTM II HPV HR Detection and HC 2 (TM II HPV HR Detection and HC 2 were 92.2% vs. 95.3% and 82.0%, vs. 80.6%, respectively, when HSIL was regarded as abnormal cytologies. In addition, the AnyplexTM II HPV HR Detection was found to have excellent intra- and inter-laboratory reproducibility (97.8% (kappa=0.952) and 97.4% (kappa=0.937), respectively). Our results thus met the criteria set Meijer et al. international guidelines.

Conclusions:

Our data show that the Anyplex IITM HPV HR Detection is clinically comparable to the clinically validated HC2 assay and can be considered clinically validated valuable tool for cervical cancer screening purposes.